Atopic DermatitisPhase 1NCT07015762
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis
A Phase 1 study testing IBI3002 in people with Atopic Dermatitis, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- IBI3002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2025to 20 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years.
- Weight ≥40kg.
- Meet the diagnostic criteria of the Hannifin \& Rajka criteria, and have been diagnosed with AD for ≥12 months at screening. If determined by Investigators, previous diagnostic terms like "dermatitis" and "eczema" are also acceptable.
- Have an Eczema area and severity index (EASI) score ≥16, the Investigator´s Global Assessment score ≥3, and the involved Body Surface Area (BSA) ≥10% at screening and randomization.
Who cannot join
- Having any disease that have an impact on the participant's own safety or participation in the study. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system, in the opinion of Investigator.
- Participants with a known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis; Or there is any other clinical evidence of latent tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first dose until the end of the study. If the participant is judged by Investigator to be intolerant to preventive anti-tuberculosis treatment, they should not be included in the study either.
- A history of malignant tumors, except for resected or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
- The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value, at screening or randomization.
- The co-existing of any other skin comorbidities that may interfere with the assessment related to AD, in the opinion of Investigators.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Naihui Zhou, 13328008259, zhounaihui@163.com
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis - a Randomized, Double-Blind, Placebo-Controlled Study
This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). The study plans to enroll patients with moderate to severe AD who have a poor response to topical treatment or who are not suitable for topical treatments. It aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, PD characteristics, and changes in clinical characteristics of these participants receiving multiple doses of IBI3002.
The entire study includes the screening period (4 weeks before dosing), the dosing period (12 weeks), and the safety follow-up period (8 weeks).
Read more
The study plans to enroll 9 to 27 participants with moderate to severe AD, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants remain blind within the same cohort.
Cohort 1: 150mg SC (IBI3002: placebo=2 :1); Cohort 2: 300mg SC (IBI3002: placebo=2 :1); Cohort 3: 600mg SC( IBI3002: placebo=2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
- Conditions
- Atopic Dermatitis
- Being tested
- IBI3002, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3002Drug
Participants with AD will receive IBI3002 at the corresponding dose and dosing interval.
PlaceboDrug
Participants with AD will receive placebo at the corresponding volume and dosing interval.
| Study group | Role | What they receive |
|---|---|---|
| Placebo 4ml SC | Placebo comparator | Participants with AD will receive Placebo 4ml SC Receives: Drug: Placebo |
| IBI3002 300mg SC | Experimental | Participants with AD will receive IBI3002 300mg SC Receives: Drug: IBI3002 |
| IBI3002 600mg SC | Experimental | Participants with AD will receive IBI3002 600mg SC Receives: Drug: IBI3002 |
| Placebo 2ml SC | Placebo comparator | Participants with AD will receive Placebo 2ml SC Receives: Drug: Placebo |
| Placebo 1ml SC | Placebo comparator | Participants with AD will receive Placebo 1ml SC Receives: Drug: Placebo |
| IBI3002 150mg SC | Experimental | Participants with AD will receive IBI3002 150mg SC Receives: Drug: IBI3002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of multiple doses of IBI3002 in Atopic Dermatitis patients.
The incidence of Adverse events (AE) and Serious Adverse events (SAE) in participants with AD after multiple doses of IBI3002;
Measured: Baseline to Week 20
Secondary outcomes (3)
To evaluate the PK parameters of IBI3002 in participants with AD;
PK parameters include, the maximum concentration (Cmax), after multiple doses.
Measured: Baseline to Week 20
To evaluate the PK parameters of IBI3002 in participants with AD;
PK parameters include, the maximum concentration (Tmax), after multiple doses.
Measured: Baseline to Week 20
To evaluate the PK parameters of IBI3002 in participants with AD;
PK parameters include, the maximum concentration (AUC), after multiple doses.
Measured: Baseline to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start14 Jul 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015762
- Sponsor's protocol ID
- CIBI3002T002
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis - a Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07015762
- Acronym / sponsor ID
- CIBI3002T002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). The study plans to enroll patients with moderate to severe AD who have a poor response to topical treatment or who are not suitable for topical treatments. It aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, PD characteristics, and changes in clinical characteristics of these participants receiving multiple doses of IBI3002.
The entire study includes the screening period (4 weeks before dosing), the dosing period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with moderate to severe AD, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants remain blind within the same cohort.
Cohort 1: 150mg SC (IBI3002: placebo=2 :1); Cohort 2: 300mg SC (IBI3002: placebo=2 :1); Cohort 3: 600mg SC( IBI3002: placebo=2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo 4ml SC | Placebo comparator | Drug: PlaceboParticipants with AD will receive Placebo 4ml SC |
| IBI3002 300mg SC | Experimental | Drug: IBI3002Participants with AD will receive IBI3002 300mg SC |
| IBI3002 600mg SC | Experimental | Drug: IBI3002Participants with AD will receive IBI3002 600mg SC |
| Placebo 2ml SC | Placebo comparator | Drug: PlaceboParticipants with AD will receive Placebo 2ml SC |
| Placebo 1ml SC | Placebo comparator | Drug: PlaceboParticipants with AD will receive Placebo 1ml SC |
| IBI3002 150mg SC | Experimental | Drug: IBI3002Participants with AD will receive IBI3002 150mg SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 65 years.
- Weight ≥40kg.
- Meet the diagnostic criteria of the Hannifin \& Rajka criteria, and have been diagnosed with AD for ≥12 months at screening. If determined by Investigators, previous diagnostic terms like "dermatitis" and "eczema" are also acceptable.
- Have an Eczema area and severity index (EASI) score ≥16, the Investigator´s Global Assessment score ≥3, and the involved Body Surface Area (BSA) ≥10% at screening and randomization.
Key exclusion criteria (6 listed)
- Having any disease that have an impact on the participant's own safety or participation in the study. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system, in the opinion of Investigator.
- Participants with a known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis; Or there is any other clinical evidence of latent tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first dose until the end of the study. If the participant is judged by Investigator to be intolerant to preventive anti-tuberculosis treatment, they should not be included in the study either.
- A history of malignant tumors, except for resected or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
- The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value, at screening or randomization.
- The co-existing of any other skin comorbidities that may interfere with the assessment related to AD, in the opinion of Investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3002Participants with AD will receive IBI3002 at the corresponding dose and dosing interval. | Drug | IBI3002 150mg SC, IBI3002 300mg SC, IBI3002 600mg SC |
| PlaceboParticipants with AD will receive placebo at the corresponding volume and dosing interval. | Drug | Placebo 1ml SC, Placebo 2ml SC, Placebo 4ml SC |
Primary outcome
To evaluate the safety and tolerability of multiple doses of IBI3002 in Atopic Dermatitis patients.
Time frame: Baseline to Week 20
The incidence of Adverse events (AE) and Serious Adverse events (SAE) in participants with AD after multiple doses of IBI3002;
3 secondary outcomes
To evaluate the PK parameters of IBI3002 in participants with AD;
Time frame: Baseline to Week 20
To evaluate the PK parameters of IBI3002 in participants with AD;
Time frame: Baseline to Week 20
To evaluate the PK parameters of IBI3002 in participants with AD;
Time frame: Baseline to Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3002 in people with Atopic Dermatitis, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wensheng Zang (15210342569, wensheng.zang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of multiple doses of IBI3002 in Atopic Dermatitis patients. (time frame: Baseline to Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.